# K020570: Simplicity

- Pathway: 510(k) (Traditional)
- Applicant: Apex Dental Materials, Inc.
- Decided: Apr 24, 2002 after 62 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945604 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945604: Ecliptomer, Bisco, Inc. (1995) Summary page 3.

## Most influential descendants
- K061981: Surpass (2006), 1 descendant of its own
- K093019: Enamelite Acryseal Spray Sealant (2009), 0 descendants of its own

## Indications for use
SIMPLICITY™ is a light cured (free radical polymerization), self-etching dental adhesive system, designed io provide a dentist with an increased ease of use that is less technique sensitive. The bonding system combines both the etchant and primer applications into -one simple step. Thus, allowing for more predictable clinical results without sacrificing bond strength integrity. SIMPLICITY™ is a universal adhesive system that when properly employed, can be used to seal enamel/dentin prior to restoring with light cured or self cured composite materials. Also, in situations of indirect restorations, the bonding system can be used to seal a preparation when using a light cured, self cured or dual cured composite cement or glass ionomer or resin-modified glass ionomer cement. In addition, the system allows the dentist to bond a post and core, along with the use to treat hypersensitive and/or exposed root surfaces.

Source page: https://510kreport.com/device/K020570
Methodology: https://510kreport.com/methodology